Under the right of access to documents in the EU treaties, as developed in Regulation 1049/2001, I am requesting documents which contain the following information:

We urgently need the following data from the EudraVigilance database:

Number of reported cases of Progressive Multifocal Leukencephalopathy (PML) related to
1. Rituximab AND
2. Natalizumab

AND clustered as follows:

a) By year (if possible cumulative for 2005 and earlier) AND
b) By the following regions:
• All
• Reported for the whole EU
• Reported for the USA

This means 72 data sets:
2 drugs x 12 periods of time x 3 regions

This is a life-threatening situation as a patient is highly concerned because of the risk to get a PML because of the treatment with one of the both drugs – although the treatment is pivotal for survival.

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